Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Inclusion Criteria:

* At least 18 years of age
* Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:

  * Radiosensitizing doses of 5-fluorouracil;
  * Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
  * Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
  * Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
* Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
* Documentation of disease progression since any prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 month
* Acceptable liver, renal function and acceptable hematological status
* Other protocol defined inclusion criteria may apply

Exclusion Criteria:

* New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease
* Symptomatic ischemic heart disease
* Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
* Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non-melanoma skin cancer or pre-invasive cancer of the cervix
* Severe chronic obstructive or other pulmonary disease with hypoxemia
* Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization
* Prior therapy with a hypoxic cytotoxin
* Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle
* Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C
* Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients
* Other protocol defined exclusion criteria may apply